BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFANT EVAQUA BREATHING CIRCUIT

    MDR report key: 1216944 · Received October 31, 2008

    Report

    Report Number
    9611451-2008-00636
    Event Type
    Death
    Date Received
    October 31, 2008
    Date of Event
    August 31, 2008
    Report Date
    October 2, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RT235 BREATHING CIRCUIT HAS NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE ("FPH") FOR INVESTIGATION. IMMEDIATELY FOLLOWING RECEIPT OF THIS COMPLAINT, WE BEGAN AN INQUIRY INTO THE CIRCUMSTANCES SURROUNDING THE EVENT. REQUESTS FOR ADDITIONAL INFO WERE PERFORMED ON AN ONGOING BASIS. THIS WAS USED TO PROVIDE THE EVENT INFO. DUE TO THE COMPLEX INTERPLAY OF CIRCUMSTANCES IN THIS SITUATION , WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THE EVENT. THE CARDIOPULMONARY SUPERVISOR AT THE HOSP REPORTED VIA AN FPH REPRESENTATIVE THAT THE PT DIED AS A RESULT OF COMPLICATIONS FROM THE HEART OPERATION (PDA LIGATION). SERRATIA HAS BEEN IDENTIFIED THROUGH INDEPENDENT SEPARATE STUDIES TO BE A NOSOCOMIAL INFECTION AND IS PREDISPOSED TOWARDS PATIENTS WHOSE IMMUNE SYSTEMS ARE PARTICULARLY VULNERABLE. RESULTS FROM THESE STUDIES IDENTIFIED CONTRIBUTARY FACTORS TO BE LOW BIRTH WEIGHT, PREMATURITY, PROLONGED RESPIRATORY THERAPY, PROLONGED USE OF ANTIBIOTICS AND MATERNAL INFECTION PRIOR TO DELIVERY. NO OTHER CASES OF NOSOCOMIAL SERRATIA INFECTIONS HAVE BEEN REPORTED TO US FROM THE HOSP. WE DO NOT EXPECT TO RECEIVE FURTHER INFO FROM THE HOSP.

    Description of Event or Problem · 1

    THE DIRECTOR OF RESPIRATORY THERAPY AT A HOSPITAL REPORTED TO FISHER & PAYKEL HEALTHCARE'S ("FPH") EASTERN REGIONAL MANAGER AS FOLLOWS: THE EVENT INVOLVED A PREMATURE INFANT WHO WAS IMMEDIATELY PLACED ON A VENTILATOR AND INTUBATED. THE EQUIPMENT SET-UP INVOLVED THE RT235 INFANT EVAQUA BREATHING CIRCUIT, MR850 HUMIDIFIER, FPH HEATER WIRE ADAPTER, FPH TEMPERATURE PROBE AND ENDOTRACHEAL TUBE. NO FILTERS WERE UTILIZED IN THE SET-UP. STERILE WATER IN A WATER BAG WAS UTILIZED FOR INHALATION PURPOSES. THE PT DEVELOPED AN INFECTION DETECTED IN THE EYE. A CULTURE IDENTIFIED THE INFECTION TO BE CAUSED BY THE BACTERIA SERRATIA. THE PT WAS TREATED WITH A COURSE OF ANTIBIOTICS FOR 9 DAYS. A CULTURE A WEEK LATER IDENTIFIED FEW SERRATIA COLONIES. THAT SAME DAY, THE PT UNDERWENT A PDA LIGATION IN THE HEART AND DETERIORATED. THE PT SUBSEQUENTLY PASSED AWAY 2 DAYS LATER FROM COMPLICATIONS AS A RESULT OF THE PDA LIGATION. THIS WAS AN ISOLATED INCIDENT OF SERRATIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT EVAQUA BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT235

    Patients

    Seq Age Sex Outcome Treatment
    1 Death FISHER & PAYKEL HEALTHCARE'S MR850 HUMIDIFIER